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Complaint Specialist - San Diego, United States - The University of Texas MD Anderson Cancer Center
Description
Job Title:
Complaint Specialist
Job Number:
34540
Location:
12390 El Camino Real San Diego,CA 92130
Job Description
Responsibilities
Conducting complaint investigations and associated tasks to ensure complaint investigations are thorough, investigation conclusions are appropriate, appropriate procedures are followed, and complaint investigations are conducted and closed in a timely manner.
Reviewing & identifying the root causes of complaints and works with the applicable operational departments such as: Product Development, Manufacturing Engineering, and Quality Engineering to ensure an appropriate resolution.
Assisting in the development of training materials and process enhancements related to complaints management.
Facilitating complaint sample returns (from consumer, pharmacy, healthcare provider or distributor) for inspection/investigation, as needed.
Participate in quality management system meetings regarding complaints and complaint handling.
Performing duties in accordance with the Company's Quality Systems and with standard operating procedures (SOPs) that are consistent with regulatory requirements and industry standards.
Performing other related duties as assigned.
Required Skills
Strong computer skills.
Proficiency with Microsoft Office business software and use of information databases
Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, Directives and Guidance
Proven ability to communicate effectively; orally and written
Ability to manage multiple tasks and projects
Able to work independently, as well as in a cross-functional team environment
Customer service oriented attitude and ability to exercise sound business judgment
Ability to maintain confidentiality and discretion in business relationships
Able to define problems, organize and collect data, establish facts, and draw valid conclusions
Background in manufacturing processes for sterile pharmaceutical products and drug-device combination products related to development and commercial programs a plus
Travel between sites as needed
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